Resources for Food and Drug Administration (FDA)Resources > FDA > Regulations
The FDA Rules and Regulations section of compliancehome.com provides you with comprehensive information and knowledge on Food and Drug Administration (FDA) Rules and Regulations. In this section of US Food and Drug Administration website find out about FDA-Regulated Industry with Information by Subject, for Small Business, Adverse Event Reporting, Compliance and Enforcement, FDA Electronic Freedom of Information Reading Room - Warning Letters and Responses, U.S. Food and Drug Administration, Center for Food Safety & Applied Nutrition's Import procedures and much more.
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Draft Guidance for The Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees
This guidance document is intended for use by FDA staff involved with advisory committee matters. This guidance document describes the factors and ana...
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems;Guidance for Industry and FDA
This guidance document was developed as a special control guidance to support the reclassification of the antimicrobial susceptibility test (AST) syst...
Collateral Damage From an FDA Warning
Ouch -- that's got to hurt. A fellow drugmaker's product got hit with an FDA warning that it could potentially cause cancer, and BioMimetic Therapeuti...
Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations
The Clinical Laboratory Improvement Amendments (CLIA) was established to strengthen federal oversight of clinical laboratories to ensure the accuracy ...
FDA CBER: Tissue Related Documents
Tissue Related Documents from US Food and Drug Administration, Center for Biologics Evaluation and Research
FDA Center for Drug Evaluation and Research: Guidance Documents
Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and d...
FDA Center for Food Safety & Applied Nutrition: Food Labeling Guidance and Regulations
These FDA Food Labeling web pages address the labeling requirements for foods under the Federal Food Drug and Cosmetic Act and its amendments. Food la...
FDA Center for Food Safety & Applied Nutrition: Seafood Information and Resources
US Food and Drug Administration, Center for Food Safety & Applied Nutrition's Seafood Information and Resources section.
FDA CFSAN: Acidified and Low-Acid Canned Foods
FDA Requirements for Establishment Registration, Thermal Process Filing, and Good Manufacturing Practices for Low-Acid Canned Foods and Acidified Food...
FDA Compliance Program Guidance Manual from Office of Regulatory Affairs
FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program...
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